A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the safety and benefits of the investigational study
drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of
Multiple Myeloma (MM).
The primary objectives:
- To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478
in combination with bortezomib (Phase I);
- To assess the overall response rate (ORR) when subjects with advanced MM are treated
(Phase II).
The secondary objectives:
- To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with
bortezomib (Phase I only);
- To evaluate for preliminary evidence of efficacy (Phase I);
- To determine progression free survival (PFS) and duration of response of KW-2478 with
bortezomib (Phase II).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Kyowa Hakko Kirin Pharma, Inc.
Collaborators:
Kyowa Hakko Kirin Company, Limited Kyowa Kirin Co., Ltd.